There are significant problems attendant to transporting and storing thermally-sensitive materials like pharmaceuticals or biologicals. The problem of temperature maintenance is compounded by the hazard of breakage when a glass container retains the temperature sensitive material. Further, the incidence of spoilage and breakage dramatically increases when one conveys containers over long distances. While shippers can deliver refrigerated containers over long distances, transporting labile payloads through normal shipping channels, without refrigeration, often results in cargo loss from exposure to extremes in temperatures. It should be noted that, while most people believe that refrigeration is a preferred method for storing and transporting pharmaceuticals, exposure to sub-ambient temperatures often results in the loss of many medications. The objective therefore for transporting pharmaceutical preparations, is to maintain a payload within a specified temperature range.
During shipping, a single manufacturing "run" of product may face unexpected exposure to extremes in temperature. For example, a delivery truck in the southwestern part of the United States may encounter the elevated temperatures of the deserts, while another shipment of the same medicine may suffer freezing temperatures of the northeast. A shipment of pharmaceuticals stored on the tarmac prior to loading on an aircraft may endure highly elevated temperatures for extended periods of time. On the other hand, once loaded in the cargo hold of an aircraft the same pharmaceuticals are often exposed to sub-freezing temperatures for prolonged periods during flight. Without a means of temperature control, the contents of traditional containers are at the mercy of the elements.
Hence, there has been a longstanding need to provide packaging that can maintain its contents at a desired temperature range while comporting with the size or weight limitations of shipping and storage.
There are many containers for transporting medicines, biologicals, and temperature-sensitive materials. Containers in accordance with the prior art are designed for transporting a particular product like insulin or nitroglycerin. Heretofore, there has been no single container that can successfully transport a variety of labile materials. In order to fulfill the requisites for multi-product shipping, a container must be adapted to transport not only nitro-glycerin or an oncology drug, but also other materials like biologically active proteins which may be susceptible to irreversible physicochemical alteration upon freezing or medicaments which lose efficacy upon exposure to elevated temperatures. The problem remaining unsolved is to design a container capable of maintaining its inner environment at a constant temperature, notwithstanding temperature changes outside the container, while being dimensionally acceptable to established shipping standards.
Another problem, long recognized yet remaining unsolved, is to provide a container that not only maintains the product safely during shipping, but also possessing the added advantage of providing a temperature controlled environment at the point of usage. For example, the container must safely hold an oncology drug in a doctor's office or insulin vials when transferred to the patient.